Condition category
Mental and Behavioural Disorders
Date applied
03/09/2010
Date assigned
27/09/2010
Last edited
27/09/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Bares

ORCID ID

Contact details

Prague Psychiatric Center
Ústavni 91
Prague 8-Bohnice
181 03
Czech Republic

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IGA MZ CR NS 10368-3

Study information

Scientific title

Randomised, open-label study comparing the efficacy of antidepressant monotherapy and antidepressant combinations in the acute treatment of patients with resistant depression

Acronym

D-REZ-KOMB

Study hypothesis

The aim of our study is to examine efficacy of antidepressant monotherapy and combinations of antidepressants in the treatment of resistant depression in common clinical practice. We will test the following null hypotheses:
1. That the reduction of depressive symptoms does not differ between monotherapy and combinations groups
2. The number of responders in both groups does not differ

Ethics approval

The Ethics Committee of Prague Psychiatric Centre approved on the 21st May 2008

Study design

Single centre two arm open label randomised active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Resistant depressive disorder

Intervention

Patients will be randomly allocated to antidepressant monotherapy group or combination of antidepressant group. Specific antidepressant will be chosen by attending psychiatrist according to clinical judgment and with regard to the history of previous treatment. Antidepressant or combinations of antidepressant will be used in the dose cited in Summary of Products. Both interventions are defined as a new intervention not augmentation of previous antidepressant treatments. We will administer combinations that are commonly used in clinical practice. The total duration of treatment is 6 weeks. We will evaluate stability of outcome in responders after 2 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The change in the Montgomery-Asberg Depression Rating Scale (MADRS). Patients will be rated at baseline, week 2 week 4 and the end of acute treatment and responders after 2 month of treatment.

Secondary outcome measures

Response to treatment that is defined as a greater than or equal to 50% reduction of MADRS score from baseline to the end of treatment.

Overall trial start date

01/01/2009

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients suffering from major depressive disorder (recurrent or single episode) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) criteria, confirmed using the Mini-International Neuropsychiatric Interview (MINI) Czech version 5.0.0.
2. Patients fulfilling at least Stage I criteria for resistant depression according to Thase and Rush, 1997
3. The mental ability to understand and sign Informed Consent Form
4. The score in Montgomery-Asberg Depression Rating Scale greater than or equal to 25 and the score in Clinical Global Impression greater than or equal to 4
5. Outpatients and inpatients
6. Age between 18 and 65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 participants

Participant exclusion criteria

1. Contraindications of used antidepressant treatments according to Summary of product (SPC)
2. The use of antidepressants as a monotherapy or as a part of combination that were ineffective in the treatment of current episode
3. The use of antipsychotics, thymostabilizers and other biological treatment of depression (ECT, rTMS, sleep deprivation etc.) during the study (anxiolytics and hypnotics for case of severe anxiety and insomnia are permitted) as well as formal psychotherapy
4. Comorbidity of Axis I and II (DSM IV) disorders in the 6 month before enrollment to the study
5. Severe or uncontrolled somatic disorders, likely to cause depressive symptoms or interfere with the conduct of the study

Recruitment start date

01/01/2009

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Prague Psychiatric Center
Prague 8-Bohnice
181 03
Czech Republic

Sponsor information

Organisation

Ministry of Health (Czech Republic) - Internal Grant Agency

Sponsor details

Palackeho nam.4
Prague 2
128 01
Czech Republic

Sponsor type

Government

Website

http://www.mzcr.cz

Funders

Funder type

Government

Funder name

Ministry of Health (Czech Republic) - Internal Grant Agency (ref: No. NS 10368-3)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes